Medication order processing and reconciliation

ABSTRACT

A system and method for managing medication orders, including verbal orders and changes to those orders, is described. A server receives mediation orders from a pharmacy and communicates those orders to an infusion pump. The infusion pump communicates status messages to the server and the server compares the status messages to the medication orders to determine if the there were any changes to the order, or if a medication was administered absent a medication order. The server assigns a new order identification number to the status message if needed. The system may also reconcile original medication orders with information associated with a new order identification number and stores the information in the eMAR of a patient.

BACKGROUND OF THE INVENTION

This invention relates generally to automated hospital informationsystems and systems for providing, monitoring and automating theadministration of medication to patients in those institutions, and inparticular to a system and method for reliably and accurately trackingmedication administration events and reconciling those events withmedications orders issued by an institutions pharmacy.

Medication delivery in a hospital or care giving institution is adaunting task that has proven to be difficult to automate. One reasonfor this is that there are many instances in such an institution wheremedication is given, or the way the medication is given, is changedwithout having a written or electronic order. Even where there is anorder in place, changes to the delivery mode, even where recorded, maynot be reconciled to the original order.

Typically, the administration of medication in an institution beginswith a physician or other authorized care giver creating a medicationorder. The order is then communicated to the institution's pharmacy,either in written form, or in electronic form. The pharmacy prepares themedication according to the order, generally assigning a uniqueidentifier to the medication order, such as a number. The intent of sucha system is to be able to track the order through the pharmacy andultimately to the patient using the unique order number.

Once the medication is prepared by the pharmacy, it is usually labeledwith information pertinent to the delivery of the medication. Forexample, in the case of a medication that is to be delivered byinfusion, a bag of infusion fluid containing a prescribed medication islabeled with information such as the medication order number, patientinformation, such as a name or other identification means, and perhapsinformation related to the delivery of the infusion fluid, such as rateof infusion or volume to be infused.

The medication is then transferred to the location of the patient, whereit is administered. In the case of a medication to be administered viainfusion, the fluid containing infusion bag is hung at the patient'sbedside, and an infusion pump is used to administer the fluid in acontrolled manner to the patient.

In some cases, one or more of the parameters used to program thedelivery of fluid to the patient are adjusted during infusion of themedication, such as when monitoring of the patient's vital signsindicates that the rate of delivery needs to be increased or decreasedto obtain a desired result. This process is call titration. In prior artsystems, such adjustments were not automatically recorded to a patient'smedication administration record, but instead needed to be manuallyentered by a care giver.

In other instances, oral orders are issued and medication delivery begunbefore receiving a medication order from the pharmacy. Again, in manyprior art systems, there was no way to automatically record and trackthis medication delivery, because there was no pharmacy generated order,and the only way to ensure that the patient's medication record wascomplete is to manually enter the information and then reconcile themanually entered record with a post delivery generated medication order.Similarly, at times, the nurse or care giver may use floor stock toreplenish a medication. Such floor stock typically carries no patientidentification information because it was not dispensed by the pharmacyfor delivery to a particular patient. While every effort is made toinsure the integrity of a patient's medication record, such manual entryand reconciliation provide opportunities for errors in the record,errors which could be avoided in a system that was capable of assigningan order identification number that could then be automaticallyreconciled with pharmacy generated medication order numbers and recordedinto a patient's medication administration record.

Accordingly, what has been needed, but heretofore unavailable, is asystem capable of recognizing actions that occur during medicationdelivery to a patient that could be due to a new order, and which isable to determine if a new order number should be applied to themedication delivery. The system would generate order identificationnumbers for each action determined to require a new order number. Such asystem would be particularly useful when used in conjunction with aninfusion system to capture orally ordered medication starts andmedication titrations, either where the titration is performed foreffect or because a new prescription is issued, to ensure a completeelectronic medication administration record. The present inventionsatisfies these and other needs.

SUMMARY OF THE INVENTION

In a general aspect, the system and method of the present invention isembodied in a system that track medication being given to a patient,determines whether an event has occurred during administration of themedication that requires a new order identification number, assigns thenew order identification system if necessary, reconciles the new orderidentification number with existing order information, if any, andupdates an electronic medication administration record for the patientwith the reconciled information.

In another aspect, the present invention is embodied in a system formanaging medication orders, comprising a server configured to receive amedication order containing medication administration information from amedication order source, a medication administration device in operablecommunication with the server, the medication administration devicecapable of receiving medication administration information from theserver, and also capable of providing the server with medicationadministration status information, wherein the server comparesmedication administration status information received from themedication administration device to the medication administrationinformation in the medication order, and if the server determines thatthere are differences between the medication administration statusinformation and the medication administration information of themedication order, the server associates a new order identificationnumber to the medication administration status information. In anotheraspect, the medication order includes a medication order number, and instill another aspect, the server associates the new order identificationnumber with the medication order number.

In a further aspect, the invention includes a medication administrationrecord database in operable communication with the server, and in yet afurther aspect, the server communicates medication administration statusinformation, including medication administration status informationassociated with the new order identification number, to the medicationadministration record database for storage in that database.

In still another aspect, the invention comprises a medicationadministration record database in operable communication with theserver, and wherein the medication status information includes themedication order number and the server communicates the medicationadministration status information, including medication administrationstatus information associated with the new order identification number,to the medication administration record database for storage in thatdatabase. In yet another aspect, the invention includes a processor incommunication with medication administration record database, theprocessor configured to reconcile medication administration statusinformation including the new order identification number withmedication order to provide a complete record of medicationadministration to a patient.

In yet another aspect, the invention is embodied in a method formanaging medication orders used to identify delivery of medication to apatient, comprising associating a medication order number to amedication order, the medication order including medicationadministration information, communicating the medication order number toa processor in communication with a medication administration device,communicating the medication administration information from theprocessor to the medication administration device, communicatingmedication administration status information from the medicationadministration device to the processor, comparing the medicationadministration status information to the medication administrationinformation of the medication administration order, and associating anew order identification number with the medication administrationstatus information if the comparison indicates a difference between themedication administration information and the medication administrationstatus information. In a further aspect, the invention includescommunicating the medication administration status information includingthe new order identification number to a medication administrationrecord database, and storing the medication administration statusinformation including the new order identification number in themedication administration record database. In a still further aspect,storing includes storing the medication administration statusinformation including the new order identification number in anelectronic medication administration record of a patient, and in yetanother aspect, the method includes reconciling the medicationadministration status information including the new order identificationnumber stored in the medication administration record database with themedication order.

In still another aspect, comparing includes applying one or more rulesselected from a database of rules to the communicated medicationadministration status information to determine if a new orderidentification number is applied to the communicated medicationadministration status information. In yet another aspect, the databaseof rules contains at least one institutionally determined rule.

In a still further aspect, the present invention is embodied in a methodfor ensuring that medication delivery changes are captured andcommunicated to an electronic medication administration record,comprising monitoring medication delivery change actions, flaggingmedication delivery change actions, determining whether a flaggedmedication delivery change action is a new medication delivery order,assigning a new order identification number to the flagged medicationdelivery change action if it is determined that the flagged changeaction is a new medication delivery order, reconciling the new orderidentification number with an original order number into electronicmedication record administration data, and updating an electronicmedication administration record with the electronic medication recordadministration data.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, the featuresof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram of an institutional informationsystem providing for communication of patient and medication relatedinformation among various institution subsystems and medical devices foradministering medication and monitoring patient vital signs;

FIG. 2 is a graphical representation of a medication administrationdevice having a central controller and various modules for deliveringmedication, monitoring patient vital signs, and for receivingidentification data related to patients, care givers and medications;

FIG. 3 is a block diagram of a process carried out ban embodiment of thepresent invention; and

FIG. 4 is block diagram of a process carried out by another embodimentof the present invention incorporating principles of the embodiment ofthe present invention illustrated in FIG. 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in detail, in which like referencenumerals indicate like or corresponding elements among the severalfigures, there is shown in FIG. 1 generally an integrated hospital-wideinformation and care management system 10. The care management systemembodiment shown in FIG. 1 is depicted as being a configured as a localarea network with a server 20 to which is connected, through aninterface 25, various hospital information and administration systems35, 40, 45 50 and 55, as well as medical devices 65, 70, 75, which maybe medication administration devices, monitoring devices, bar codereaders and the like. In the embodiment shown, medical devices 65, 70and 75 communicate with server 20 via a wireless communication systemutilizing a wireless access point 60.

While the system described above is described as a local area network,other network configurations are possible. For example, the network maybe configured as a wide area network, or the network may be configuredincluding remote computers and databases, or may utilize the internet orother communication means to provide for remote control and data flowwithin the network.

Referring again to FIG. 1, the server 20 stores programs and datacollected by the various computers and systems in the local areanetwork. Various application modules of the patient management systemmay be resident in each of the computers in the network and will bediscussed in more detail below. Ethernet cabling of a local area network30 is used to connect various computers and information systems to theserver 20. The server 20 may also have both local and network hard diskstorage for storing programs as well as data gathered on the network.

As shown in FIG. 1, various subsystems of a facility's informationmanagement system are connected together by way of the communicationsystem 30. The communication system 30 may be, for example, a local areanetwork (LAN), a wide area network (WAN), Internet- or Intranet-based,or some other telecommunications network designed to carry signalsallowing communications between the various information systems in thefacility. For example, as shown in FIG. 1, the communication system 30connects, through various one or more interfaces 20 (only one shown), apharmacy information system 35, a hospital administration system 40, aan electronic medication administration record systems 45, physicianorder entry system 50, and other systems 55, which may be, for example,a laboratory data system, a paging system, an alerts management system,a report generating system, and the like.

Each of the various systems 20, 35, 40, 45, 50 and 55 are typicallyinterconnected via the network 30 and appropriate interfaces 20, andgenerally comprise a combination of hardware such as digital computerswhich may include one or more central processing units, high speedinstruction and data storage, on-line mass storage of operating softwareand short term storage of data, off-line long-term storage of data, suchas removable disk drive platters, CD ROMs, or magnetic tape, and avariety of communication ports for connecting to modems, local or widearea networks, such as the network 30, and printers for generatingreports. Such systems may also include remote terminals including videodisplays and keyboards, touch screens, printers and interfaces to avariety of clinical devices. The processors or CPUs of the varioussystems are typically controlled by a computer program or programs forcarrying out various aspects of the present invention, as will bediscussed more fully below, and basic operational software, such as aWindows™ operating system, such as Windows NT™, Windows 2000™, orWindows XP™, distributed by Microsoft, Inc., or another operatingprogram distributed, for example, by Linux, Red Hat, or any othersuitable operating system. The operational software will also includevarious auxiliary programs enabling communications with other hardwareor networks, data input and output and report generation and printing,among other functions.

The communication system 30 may comprise, for example, an Ethernet (IEEE522.3), a token ring network, or other suitable network topology,utilizing either wire or optical telecommunication cabling. In analternative embodiment, the communication system 30 may comprise awireless system, utilizing transmitters and receivers positionedthroughout the care-giving facility and/or attached to variouscomputers, clinical devices and other equipment used in the facility. Insuch a wireless system, the signals transmitted and received by thesystem could be radio frequency (RF), infrared (IR), or other meanscapable of carrying information in a wireless manner between deviceshaving appropriate transmitters or receivers may be used. It will beimmediately understood by those skilled in the art that such a systemmay be identical to the system set forth in FIG. 1, with the exceptionthat no wires are required to interconnect the various aspects of thesystem.

In the embodiment shown, the server 20 of the care management system isconnected by the local area network (LAN) 30 to computers and otherperipheral equipment located in the institution's pharmacy, at nursingstations located throughout the institution, and at the patient'sbedside. In one embodiment, the module located in the pharmacy maycomprise a central processing unit to which is attached a video displayand a keyboard for entry and display of patient information and drugparameters. Also attached to the pharmacy CPU is a bar code reader whichis adapted to read barcode labels that may be attached to drugcontainers, equipment, or caregiver identification badges. Alsoconnected to the pharmacy CPU may be a bar code printer and a printerused for generating reports containing information about patient historyand/or patient treatment. The printer may also be used to print barcodelabels generated by the pharmacy CPU after patient or drug data is inputby a technician or pharmacist into the pharmacy computer using thekeyboard or other means. In accordance with one embodiment of thepresent invention, the pharmacy CPU is located at a central pharmacythat serves an entire healthcare facility or a particular section orunit of the facility. As will be discussed in more detail below, withthe use of the pharmacy CPU, a pharmacist can monitor all medicationorders for the facility or specified unit, as well as the progress ofthose orders, and manage the administration of medication to ensure thatthe medication is administered to the right patient, in the right dose,along the right route and at the right time.

In some embodiments, the system may also include another computer,located at a nursing station. Nursing stations are typically located invarious sections and/or floors of a hospital or clinic and generallyprovide a central location for record storage and monitoring for anumber of patient beds. The nursing computer or CPU located at the nursestation typically includes a video display for displaying patient orother information pertaining to the operation of the particular unit ofthe institution, and a keyboard, mouse, touch screen, or other means forentering patient data or specific commands instructing the nursing CPUto generate reports relating to either the patient's medical history orthe course and progress of treatment for an individual patient on theattached printer or on the video display. The nursing station CPU mayalso generate other reports such as, for example, a printout of drugsscheduled to be administered to patients, productivity measurements suchas, for example, the amount of time a nurse spends with a patient orother reports useful for assisting in the efficient operation of theparticular unit or the hospital. For example, a report listing theactual times of administration versus the scheduled times foradministration may be prepared to assist in evaluation of staffingrequirements.

Each care unit associated with the nursing station typically comprisesone or more patient beds located in private rooms, shared rooms, or openor semi-open wards that contain multiple beds. In accordance with anembodiment of the present invention, each private room, semi-privateroom, or ward area has at least one medical device for deliveringmedication and/or monitoring the status of a patient located therein.The medical device may have a central controller or CPU for controllingmedication administration and for gathering dated related to medicationadministration and patient status. Moreover, each patient bed or groupof beds may also have a bedside computer or CPU for monitoring andcontrolling one or more medical devices for treating patients. Insystems having bedside computers, the bedside CPU may include a videodisplay and a keyboard, mouse, touch screen or other device. The bedsideCPU can be used by a nurse, physician or technician to access a varietyof institutional databases to display a variety of information about aparticular patient. This information can include an on-line, real-time,graphical patient medication administration record (eMAR) that ismaintained separately from other systems or that is derived from thepatient's medication profile maintained by another system in thehospital, such as by the hospital's pharmacy information system 35, thehospital information system 40 or other systems.

The bedside CPU also allows remote access to a patient's records storedby the server 20 to display medication history for the patient. Thismedication history includes a listing of all drug or other treatmentsgiven to the patient, including past, present and future deliveries ofmedications to the patient. While a bedside CPU has been described, itwill be understood that what is intended is a system having a computeror processor located in the general vicinity of a patient. Such acomputer or processor, besides being embodied in a bedside computer, mayalso be incorporated in a handheld or vital signs device, a laptopcomputer, a personal digital assistant (PDA), a controller for aninfusion pump, or any other suitable device having a processor capableof being programmed to carry out the functions described above.

In one embodiment of the present invention, the bedside CPU furtherincludes a database including a library or libraries of informationconcerning past and present medical administration activities and/orinstitutional guidelines for appropriate parameters for administrationof various medications. For example, the guidelines may includeinstitutionally established guidelines or limits on drug administrationparameters, such as dosage, frequency of administration, and otherdelivery related information such as, for example, appropriate flowrates and infusion durations for programming infusion pumps.Additionally, the guidelines may encompass guidelines or rules forproviding drug administration appropriate to particular patienttreatment areas having different sets of delivery parameters for similarmedications, such as medication administration directed to geriatric,pediatric and oncology patients. Guidelines may also be included thatare directed to particular therapy regimens, such as chemotherapyregimens or regimens for treating chronic infection or pain. Theguidelines library stored in the bedside CPUs may be accessible by themedication administration devices during programming of an infusion.Alternatively, the database may be stored directly in the medicationadministration device or another computer connected to the network andaccessible by the medication administration device. In one embodiment,the database may be stored in the server 20 or the pharmacy informationsystem 35 and accessed and controlled by the central pharmacy tosupervise medication administrations delivered by the medicationadministration device. In another embodiment, the database may be storedin a mobile device, such as a notebook computer, PDA, computer onwheels, or the like.

Each bedside CPU, or medical device including a suitably programmedprocessor, computer or controller, can be connected through anappropriate interface to a variety of peripheral equipment. For example,the system may include a barcode reader capable of reading barcodes on apatient's wristband or medication container; an infusion pump fordelivering medication to the patient in a predetermined, controlledmanner; or various sensors that can automatically monitor a patient'svital signs and send signals representative of these vital signs to thecomputer through an appropriate interface for storage and laterretrieval by a selected software application to provide a graphicdisplay of the patient's vital signs during the course of treatment.

In a different embodiment where RFID (RF identification) tags may beused with medication, patients, equipment, or in other ways, the bedsideCPU may also include an interrogator or RFID reader (not shown) for usewith the RFID tags.

FIG. 2 illustrates one embodiment of a bedside medication administrationdevice 100 capable of controlling and monitoring one or more medicationdelivery devices, vital signs monitors and/or identification modules. Inthe system depicted in FIG. 2, four different functional units are shownmounted on and in operable communication with a central controller 105.Central controller 105 includes a processor, memory and a communicationsport for providing a communication pathway to and from the hospital'snetwork 30 (FIG. 1).

Functional units shown include an infusion pump unit 110, a syringe pump115, a pulse oximeter 120, and a bar code reader 125. In one embodiment,it would be possible to select a functional unit to perform a particularfunction or procedure through controller 105 by depressing anappropriate softkey or hardkey programmed to associate a functional unitwith the display of the central controller 105. When the desiredfunctional unit is selected, display 102 of the controller 105 isconfigured so as to act as the user interface for the selectedfunctional unit. More specifically, display 102 is configured inaccordance with a function specific domain to provide function specificdisplays and softkeys which may be operated to program and operate thefunctional unit.

Infusion pump unit 110 shown in FIG. 2 is a pumping unit for basic fluidinfusion. Infusion pump unit 110 includes a system to control thevarious functions performed by such a pump, which include the control offluid delivery to the patient and the monitoring of the fluid path forocclusion or air-in-line. Infusion pump unit 110 may contains one ormore displays, such as a rate display used to display the actualinfusion rate at which the pump is operating and a channel messagedisplay used to display informational, advisory, alarm, or malfunctionmessages. Infusion pump unit 110 may also contains a plurality ofindicators, which illustratively illuminate when the functional unit isin alarm or infusion complete condition, when the functional unit isprogrammed for a future start time or has been paused, or when thefunctional unit is performing an infusion. Other appropriate indicatorsmay be included in other functional units.

Also shown in FIG. 2 is syringe pump 115, a pulse oximeter 120 and a barcode reader module 125. Syringe pump 115, pulse oximeter 120 and the barcode reader module 125 may each contain a set of hardkeys and/orsoftkeys for operating the functional unit. Each of the functional unitsmay also include one or more displays and a plurality of indicatorswhich may be used to display appropriate information.

With the advent of computers and networking capabilities, hospitals andother care giving institutions have developed or purchased varioussystems for recording and tracking the treatment given to patients. Onemethod commonly used is the recording and maintaining of an electronicmedication administration record, typically called an eMAR, thatcontains details of each medication administration given to a patient inthe institution. The eMAR is a document that, to be useful, must beaccurate, and contain a complete record of a patient's treatment.

A patient entering a hospital or other care giving facility is providedwith a wristband, necklace, ankle band or other identifier that isaffixed to the patient in a manner so that the patient can be identifiedeven if the patient is unconscious or otherwise unresponsive. Thiswristband or other device may include a bar code representing the nameof the patient and other information that the institution has determinedis important. Additionally, any other information such as age,allergies, or other vital information may be encoded into the bar code.Alternatively, the patient information device may be an active embeddedcomputer or passive device attached to a wrist band or other carrierthat is attached to the patient. Such a device would be responsive todevices located throughout the care-giving facility, such as readers orwireless transmitter/receivers, to provide the identity of the patientalong with other information when the device is queried.

After the patient is admitted and situated in a bed within the facility,the patient is typically evaluated by a physician and a course oftreatment is prescribed. The physician prescribes a course of treatmentby preparing an order which may request a series of laboratory tests oradministration of a particular medication to the patient. In some case,the physician prepares the order by filling in a form or writing theorder on a slip of paper to be entered into the hospital system forproviding care. In other cases, the physician may enter the medicationorder directly into a physician order entry system 50 (FIG. 1) or mayinstruct a nurse or other care-giving professional to do so.

If the order is for administration of a particular medication regimen,the order will be transmitted to the facility's pharmacy informationsystem 35. Using the pharmacy CPU, the pharmacy reviews the order. Thepharmacy information system 35 typically checks each order against adatabase of medication related information for incompatibilities,including interactions with other drugs and with patient conditions,such as patient allergies, diseases, and vital signs. If noincompatibilities are detected, the pharmacy prepares the medicationaccording to the requirements of the physician. Typically, the pharmacypackages the medication in a container, and a copy of the order, or at aminimum the patient's name, the drug name, and the appropriate treatmentparameters, including a medication order identification number, arerepresented on a label that is affixed to the drug container. Thisinformation may be represented by a bar code, or it may be stored in asmart label, such as a label having an embedded computer or passivedevice.

Once the order has been prepared, the order is sent to the nurse stationfor matching with the appropriate patient. Alternatively, if themedication is for a commonly or routinely prescribed medication, themedication may be included in an inventory of medications that is storedin a secure cabinet adjacent the nurse station. In such a case, thenurse station will receive from the pharmacy a list of the orders storedin the pharmacy information system 35 that may be drawn from theinventory adjacent the nurse station. The nurse enters her identifier atthe cabinet to gain access, in accordance with standard practice. Thenurse or other professional assigned the task of gathering medicationsthen matches the orders received from the pharmacy information system 35to the medications stored in the inventory and pulls those medicationsthat are to be delivered to specific patients. These procedures arecarried out whether the medication to be delivered is an oralmedication, or a medication that is to be delivered intramuscularly orthrough an infusion.

When the prescribed time for delivery of the medications arrives, themedications are carried to the patient's area and administered to thepatient by the nurse or other care-giver. In the case of drugs to bedelivered via infusion, the care-giver hangs the infusion bag, attachesthe bag to an infusion pump, and sets up the infusion pump to deliverthe medication by programming the pump with values for variousparameters that are used by the pump to control delivery of themedication to the patient.

For certain drugs, the care-giver is prompted to enter data descriptiveof a selected patient parameter or parameters, such a laboratory valueor a current vital sign, before completing the verification process. Forexample, the care-giver may be prompted to measure and enter a value fora patient's blood pressure before administering certain selected drugs.The system may include ranges of acceptable values for the parameters.If the system detects an out-of-range value for the parameter, thesystem causes an alarm to be provided. In an alternative embodiment, theparameters could be monitored and entered into the system automatically,eliminating the need for manual entry by the care-giver.

Once the medication delivery parameters and any other data is enteredinto the pump, the data is communicated to server 20 (FIG. 1) which inturn may communicate the information to the pharmacy information system35, hospital administration system 40, eMAR system 45 or other systemfor recordation, monitoring and/or analysis. Typically, the informationis communicated by the server over network 30 to the eMAR system 45which records the therapeutic regimen information in the patient's eMAR,and verifies that the right medication is being given to the rightpatient in the right dose by the right route and at the right time.

In an embodiment of the present invention, where the medication is to bedelivered using an infusion pump, such as the infusion pump 110 attachedto the central controller 105 (FIG. 2), the care management system maybe programmed to automatically download information consisting of theappropriate configuration parameters for the infusion from the pharmacyCPU through the network 30, server 20 and wireless access point 60. Thesignals transmitted from the wireless access point 60 are received bymedical devices 65, 70 and 75, which may be a controller/pump systemsuch as that shown in FIG. 2. Such configuration parameters aredownloaded into the pump 110 to program the operation of the pump whenthe verification function that is carried out either in the processor ofthe central controller 105, the server 20, or in some other hospitalinformation system is complete. This is particularly advantageous inthat one potential source of inaccuracy is eliminated by automaticallyconfiguring the pump, thus eliminating the need for the nurse ortechnician to manually enter the parameters necessary to configure theinfusion pump. In an embodiment where the pump cannot be automaticallyconfigured by downloading parameters from the network, the caremanagement system only verifies that the right treatment is beingadministered to the right patient. The pump must then be manuallyconfigured by the physician, nurse or technician.

In one embodiment of the present invention, institutional guidelines forappropriate parameters associated with the entered parameters such asmaximum and minimum doses may be stored in the database along with theguidelines relating to drug and patient condition incompatibilities. Thepump, or other medication administration device, may also have adatabase of guidelines for appropriate parameters associated with theentered parameters stored within a memory associated with the pump ormedication administration device. In the case where patient care systemsor medication administration devices are connected to a hospital server,such a database may also be located at the hospital server and thepatient care system or medication administration device communicateswith the server during the verification stage to obtain the acceptableranges. In another embodiment, the library may be located in a portabledata assistant (herein “PDA”) such as a Palm Pilot™ with which thepatient care system or medication administration device may communicatevia infrared link, RF, blue tooth, or by other means. The nurse orcare-giver may carry the PDA and before the patient care system ormedication administration device will begin operation, it mustcommunicate with the PDA to compare the hard and soft limits against theentered values.

Once medication administration values have been entered into the patientcare system or medication administration device by a nurse or othercare-giver, these values are checked against the stored database toverify that the selected values are within acceptable ranges. If aselected value contravenes a hard limit, the processor will alarm andrequire a value change before operation of the medication administrationdevice can begin. If the selected value contravenes a soft limit, theprocessor of the medication administration device will require anacknowledgment from the nurse or other care-giver that he or sheunderstands the value entered is outside a soft limit and that thisvalue is nevertheless to remain in force.

Storing a data base of institutional standards for drug infusionparameters and physiological parameter limits, such as, for example, themaximum and minimum concentrations of CO₂ and SpO₂ and the maximum andminimum values of respiration rate, also aids in standardizing thequality of care in a clinical setting. In some embodiments, infusionparameter values or physiological parameter limits may be enteredautomatically from a machine-readable label, for example using a barcode reader mounted on the bag or on the syringe or other medical fluidcontainer in which the medical fluid to be infused is stored. In otherembodiments, such infusion parameter values and physiological parametervalues may also be entered by other means, such as through a connectionwith an external processor, such as a hospital server, throughconnection to a PDA, or other institutional systems. Connections withthese devices may be made in various ways, such as direct, hardwiredconnection, infrared link, blue tooth link, or the like as know to thoseskilled in the art.

The medical database system of one embodiment of the present inventionreceives medication administration information from a nurse orcare-giver prior to medication administration, compares that informationto institutionally established guidelines for administration of variousmedications, and provides an alert if any or all of the medicationadministration information received from the medication administrationdevice falls outside of the guidelines stored within the medicaldatabase. This allows the nurse or care-giver administering themedication to correct the administration parameters entered into themedication administration device before medication administration to thepatient is begun. If the administration information falls within theguidelines, the nurse or care-giver may receive a message thatmedication administration may begin. In one embodiment, the medicationadministration device may be “locked out”, that is, electronicallyprevented from beginning administration of the medication until themedication administration device receives a signal from the processorthat the administration parameters entered into the administrationdevice are appropriate for the medication and that institutionalguidelines for the administration have been met, unlocking themedication administration device and allowing the care-giver to beginmedication administration.

Once the infusion pump or other medication administration device isconfigured, the nurse, caregiver, or technician starts the infusion bypressing the appropriate control on the infusion pump 110. Starting apump that is capable of being monitored automatically by the caremanagement system causes a signal to be transmitted from the pump 110through controller 105 to the wireless access point connected to server20 (FIG. 1). Server 20 may then keep a record of the medicationadministration in its own memory or database, or may also communicatethe relevant information to the hospital system, such as the eMAR system45, for recordation in the patient's eMAR.

It will immediately be apparent to those skilled in the art that themedication order number is central to maintaining an accurate andcomplete record of medications delivered to a patients. All medicationadministrations are identified by a unique medication orderidentification number, which is then associated with a patient.

One problem that arises, however, is that changes may be made to aninfusion regimen after the initial start of the infusion is recorded inthe eMAR. However, these changes must also be recorded in the patient'seMAR to ensure a complete record of the medications given to thepatient. Prior systems have not been capable of tracking these changes.

Moreover, in some situations, such as in the emergency room, or duringan operation under anesthesia, oral orders are given for theadministration of medications. In such cases, there is no pharmacygenerated medication order identification number assigned, and so thereis no way to ensure that the information is accurately communicated toand stored in the eMAR system.

FIG. 3 contains a block diagram graphically illustrating a generalembodiment of the system and method of the present invention. Amedication delivery change action is detected by a medication deliverydevice, such as a suitably programmable infusion pump or centralcontroller 105 (FIG. 2) in box 150. Medication delivery change actionsmay be actions such as the start up of the pump to deliver a newmedication and the initiation of a medication delivery, the restart ofthe pump when a new bag is hung to replace a depleted bag of infusate, achange in the rate of medication delivery, a change in the amount ofmedication to be delivered, or other similar actions that may berequired to be recorded to ensure a complete and accurate eMAR.

The pump flags the actions in box 155, identifying the action as onewhere a determination needs to be made as to whether a new orderidentification number should assigned to the action. The determinationas to whether a new order identification number needs to be assigned tothe flagged action occurs in box 160. A rules engine resident in thememory of the medication delivery device, or which is resident on aserver, is then applied to the flagged action to determine the action isa new order that requires a new order identification number.

The rules engine, depending on where it is resident, may take differentactions. For example, where the rules engine is resident on the pump, itmay be programmed to take a conservative course of action and apply anew order number to each flagged action. If the rules engine is residenton a server, and acts on flagged actions communicated to the server bythe pump, the rules engine may be more flexible, or may be programmedwith institutional specific rules. Such institutional specific rules,for example, may include rules that determine that a flagged action doesnot require a new order identification.

If the rules engine determines that a flagged action is not a new order,the program branches to box 165, and no further action is taken, andmedication delivery continues. If a flagged action is determined to be anew order, a new order identification number is assigned in box 170.

Medication administration information is then communicated to a serverwhere the new order number is reconciled with the original order numberassociated with the medication delivery to ensure that the eMAR of thepatient is complete and accurate. This reconciliation process may alsobe carried out in accordance with an institutionally developed set ofrules which are applied to the various actions identified with ordernumbers to determine if the new order numbers should be considered asseparate actions that require reconciliation with original ordernumbers. For example, in a system in accordance with one embodiment ofthe present invention, the program running on the server may deflag anaction if it determines that the flagged action should not be accorded anew identification number. Such a system is particularly advantageous inthat the pump can be programmed to flag each new action to ensure nochange actions are missed, and the server can then determine, inaccordance with institutional rules, whether each change actually needsa new identification number that will in turn need to be reconciled toan original order number. Once the reconciliation process is complete,the patient's eMAR is updated in box 180.

The specific activities carried out by the medication delivery deviceand server depend on the capabilities of the medication delivery device.For example, where the medication delivery device includes a suitablypowerful processor, the new order identification number may be generatedby the pump and the server accepts it for reconciliation. If themedication delivery device is not sufficiently intelligent, that is,does not include a suitably powerful processor, or lacks sufficientmemory, and the like, the server may be configured to flag each actioncommunicated to it and determine whether or not to assign a newidentification order number.

A more detailed embodiment of a system and method in accordance with thepresent invention is illustrated by the flow chart of FIG. 4. As innormal practice, the pharmacy prepares a medication for delivery andissues an order identification number (“Pharm ID”) in box 200. The PharmID, along with all of the other information necessary to administer themedication is then transmitted through the network 30 (FIG. 1) to theserver 20 in box 205. In turn, the medication order is transmittedthrough the network to the appropriate medical device 65, 70, 75, whichmay be, for example, an infusion pump such as the Medley™ sold byCardinal Health, for delivery to the patient in box 210.

As described previously, a medication administration device such as theMedley infusion system includes a central controller having a memory forstoring computer programming and operational software and infusion andpatient related data. The processor of the central controller can beprogrammed to both control the flow of programming commands into afunctional module, such as an infusion pump, and also monitor thefunctional module for status information related to either the patient,the medication delivery, or both. The programming commands used tocontrol the operation of the functional unit are typically received fromserver 20, which, as described, may receive them from another hospitalsystem, such as the pharmacy information system 35. Alternatively, thecentral controller may receive programming commands directly from ahospital system.

At a predetermined time, a care giver will go to the patient's bedsideto initiate delivery of an ordered medication. In the embodimentdescribed, where the medication is to be given as an infusion, the caregiver hangs the infusion bag containing the ordered infusate at thepatient's bedside. At that time, depending on the system used by thehospital, the care giver may use an identification device, such as a barcode reader, to input the identification of the patient, theidentification of the medication, and perhaps the identification of thecare giver. If suitably programmed, the processor of the centralcontroller of the medication administration device compares thepatient's identification to that associated with the medicationidentification to ensure that the right medication is being given to theright patient. If this comparison is satisfied, then the server 20 maycommunicate various operating commands or configuration or operatingparameters to the processor of the central controller to program thefunctional unit to deliver the medication as ordered. Alternatively, theoperating commands or parameters may have already been communicated tothe processor of the central controller, and a satisfied comparison ofidentification data allows the programming of the processor of thecentral controller to proceed to program the functional unit inaccordance with those operating commands or parameters.

Additionally, the server 20 or the processor of the central controllermay be programmed to carry out additional evaluation of the programmingcommands or operating parameters to be used to program the functionalunit, particularly if one or more of the commands or parameters isentered or changed manually by the care giver. The commands andparameters may be compared by the processor to a library of guidelinesand rules established by the hospital or institution. If the comparisonindicates that the entry is outside of the established guideline orviolates a rule, an alert may be provided, and the delivery of themedication halted or blocked until the entry is corrected.

Once all comparisons are completed and the processor of the centralcontroller of the medication administration device determines that theright drug is being given to the right patient in the right form anddosage, and also at the right time, if the system is programmed toevaluate that parameter, the delivery of the medication may begin. Whilethe system may be programmed to automatically start the infusion,typically the start of medication delivery is initiated by the caregiver pressing a button, a key or actuating a mouse or some other meanson the medication administration device or in communication with themedication administration device in box 215 (FIG. 3). In any case, oncethe medication delivery is actually started, the processor of thecentral controller assigns an internal order identification number(Internal ID) to the medication delivery in box 220. It will beunderstood that the Internal ID may be assigned to the medication orderat any time once the medication order is received by the centralcontroller; thus the scope of the invention is not limited to assigningan Internal ID only after initiation of medication delivery.

Depending on the programming of the central controller of the medicationadministration device 65, 70, 75 and the server 20 (FIG. 1), the centralcontroller of the medication administration device may monitor thedelivery of the medication and provide the server with periodic statusmessages containing information related to the delivery of themedication in box 225. These messages are coded with the Pharm ID andalso the Internal ID, among other delivery related information. Thesemessages may be provided to the server 20 by the central controller ofthe medication administration device either in an unsolicited manner,that is, they are sent to the server at predetermined intervals, or theymay be solicited by the server. By this it is meant that the server 20,either automatically polls the medication administration device atselected intervals, or the server 20 polls the medication administrationdevice upon request from a system user, to solicit a status message fromthe medication administration device.

Once the status message is received by the server 20, the serverprocesses the information contained in the status message to determinewhat action should be taken next. For example, the server correlates thePharm ID and Internal ID to determine if any action needs to take place.Alternatively, the server, in box 230, may perform such tasks as, forexample, transposing status information as needed, matching informationfields or identifications, cross referencing information as needed,forming new records from the status information, and linking the newrecords to existing records.

One important process carried out by the server 20 is to correlate thePharm ID with the information associated with the Internal ID todetermine if there were any changes to the medication order transmittedby the pharmacy information system 35. If the correlation process in box235 indicates that nothing has changed, meaning that the medication wasactually dispensed to the patient as was directed in the medicationorder, then the server sends a record or message in box 240 to the eMARsystem 45 containing information that is used by the eMAR system toupdate a patient's eMAR to reflect the treatment administered to thepatient.

If the correlation process of box 235 carried out by the serverindicates that a change has occurred, meaning that the medication wasnot delivered as prescribed in the original medication order, the server20 issues a New Order ID and associates it with the informationcontained in the status message related to the delivery of themedication. After assigning the New Order ID in box 245, the serverprepares a message containing data related to the delivery of themedication and transmits the message to the eMAR system 45 to update thepatient's eMAR. In this way, a patient's eMAR contains all informationrelated to the delivery of medication to the patient, and not justinformation related to the original medication order. This isparticularly advantageous in that the system thus captures any changesmade during delivery of the medication, such as, for example, when acare giver finds it necessary or desirable to titrate the delivery ofmedication to a patient using an infusion pump.

An alternative embodiment of the present invention includes theadditional process, illustrated by box 250 of FIG. 3, whereby either theserver 20, of some other hospital system, reconciles the various entriesin the eMAR system for a patient to capture the medication history ofthe patient. In this process, the server 20 or other hospital systemprocesses and arranges the records of the eMAR such that reports can begenerated, viewed and printed wherein a care giver inspecting the reportcan easily see not only the original medication order, but also,typically in time order, the sequence of any changes that were made tothe original medication by a care giver.

The correlation process carried out by the server 20 in box 235 (FIG. 3)may be performed in various ways, and the present invention is notintended to be limited by any particular process. For example, theserver may analyze the status message received from the medicationadministration device by comparing the infusion status messages againstthe patient orders. If the status message fits another order better thanthe one it is reported against, the message will be flagged and the NewOrder ID assigned. This comparison may be done simply by matching datafields and detecting when a field differs from the original order, or itmay be done using more sophisticated approaches, such as using a patternmatching algorithm, which may also include fuzzy logic, to determinewhich orders an infusion message best fits. One advantage of using apattern matching algorithm is that status messages would not be requiredto exactly match an original order in length or content, and yet theserver would still be able to analyze the message and match it up to anexisting order.

Occasionally, a medication will be administered without any writtenorder. Such an event may occur, for example, in the emergency room ormay result from a verbal order given by an anesthesiologist duringsurgery. In such a case, the infusion bag is hung, the appropriateoperating commands or parameters are entered into the infusion pump, andthe administration is initiated by the care giver to deliver themedication to the patient. In such a case the process begins at box 215of FIG. 3. The ensuing process, however, is very similar to thatdescribed above, the only difference being that there is no Pharm ID,since the medication delivery did not originate in the pharmacy system45.

As previously described, initiation of medication administration in box215 results in the medication administration device, here an infusionpump, assigning an Internal Order ID in box 220. When the serverreceives a status message transmitted by the infusion pump in box 225,the server attempts to correlate the Internal ID with a Pharm ID in box230. Because there is no Pharm ID, the correlation analysis carried outin box 230 necessarily results in the program branching in box 235 tobox 245, where the server issues a New Order ID. This New Order ID isthen transmitted to the eMAR system 45 to update the patient's eMAR inbox 240. In this manner, the system of the present inventionautomatically accounts for all medication administrations given to apatient, and ensures that the patient's eMAR accurately reflects thecare that the patient received. The system of the present inventionaccomplishes this automatically, thus reducing the amount of manualrecord keeping and reconciliation that would otherwise be performed by acare giver or other staff member of the hospital or institution.Moreover, elimination of manual steps reduces the possibility of errorsin transcribing and reconciling the information input into the patient'seMAR.

While several particular forms of the invention have been illustratedand described, it will be apparent that various modifications can bemade without departing from the spirit and scope of the invention.

I claim:
 1. A system for managing medication orders, comprising: aprocessor configured to receive a medication order from a medicationorder source, the medication order comprising a first orderidentification number and instructions regarding how to deliver amedication; and a medication administration device in operablecommunication with the processor, the medication administration deviceconfigured to receive the medication order from the processor, andprovide the processor with medication administration status informationcomprising the first order identification number, an internal orderidentification number, and information regarding the actual delivery ofthe medication; wherein the processor is further configured to: comparethe medication administration status to the medication order, and assigna second order identification number to the medication administrationstatus information if the actual delivery of the medication does notmatch the instructions in the medication order, or retain the firstorder identification number if the actual delivery of the medicationdoes match the instructions in the medication order.
 2. The system ofclaim 1, wherein the processor is further configured to associate thesecond order identification number with the first order identificationnumber.
 3. The system of claim 1, further comprising a medicationadministration record database in operable communication with theprocessor.
 4. The system of claim 3, wherein the processor is furtherconfigured, if a second order identification number is assigned, tocommunicate the second order identification number and the informationregarding the actual delivery of the medication to the medicationadministration record database for storage in that database.
 5. Thesystem of claim 3, wherein the processor is further configured, if asecond order identification number is not assigned, to communicate thefirst order identification number and the information regarding theactual delivery of the medication to the medication administrationrecord database for storage in that database.
 6. The system of claim 1,wherein the processor is included in a server that is in operablecommunication with the medication administration device.
 7. The systemof claim 1, wherein the processor is included in a central controllerconfigured to control one or more functions of the medicationadministration device.
 8. The system of claim 1, wherein the medicationadministration device is an infusion pump.
 9. A method for managingmedication orders, the method comprising the steps of: preparing amedication order comprising a first order identification number andinstructions regarding how to deliver a medication; communicating themedication order to a processor; communicating the medication order fromthe processor to a medication administration device; communicatingmedication administration status information from the medicationadministration device to the processor, the medication administrationinformation comprising the first order identification number andinformation regarding the actual delivery of the medication; comparingthe medication administration status information to the medicationorder; and assigning a second order identification number to themedication administration status information if the actual delivery ofthe medication does not match the instructions in the medication order,or retain the first order identification number if the actual deliveryof the medication does match the instructions in the medication order.10. The method of claim 9, further comprising the steps of:communicating, if a second order identification number is assigned, thesecond order identification number and the information regarding theactual delivery of the medication to a medication administration recorddatabase; and storing the second order identification number and theinformation regarding the actual delivery of the medication in themedication administration record database.
 11. The method of claim 10,wherein the medication administration record database comprises anelectronic medication administration (eMAR) record of a patient.
 12. Themethod of claim 10, further comprising the step of: reconciling themedication administration status information with the medication order.13. The method of claim 9, further comprising the steps of:communicating, if a second order identification number is not assigned,the first order identification number and the information regarding theactual delivery of the medication to a medication administration recorddatabase; and storing the first order identification number and theinformation regarding the actual delivery of the medication in themedication administration record database.
 14. A method for ensuringthat medication delivery changes are captured and communicated to anelectronic medication administration record, the method comprising thesteps of: flagging with a medication delivery device a medicationdelivery change between a prescribed delivery of a medication in amedication order and an actual delivery of the medication, themedication order comprising a first order identification number;determining with a processor whether the flagged medication deliverychange requires assignment of a second order identification number;assigning a second order identification number to the flagged medicationdelivery change based on the step of determining; updating, if a secondorder identification number is assigned, an electronic medicationadministration record (eMAR) with the actual delivery of the medicationand the second order identification number; and updating, if a secondorder identification number is not assigned, the eMAR with the actualdelivery of the medication and the first order identification number.